StrokeNCT03205527
Perturbation Training for Fall-risk Reduction Among Stroke Survivors
A study testing Overground slip perturbation training in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Overground slip perturbation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will have to be ambulatory (with or without assistive device) with self-reported chronic (> 6 months) stroke-induced hemiparesis confirmed by participants' physician and medically cleared. Evidence of unilateral brain lesion confirmed by an imaging study (e.g. CT or MRI).
- Subjects with no other acute and significant neurological, cardiopulmonary, musculoskeletal or systemic diagnosis or have undergone a recent major surgery (<6 months) or hospitalization (<3 months) and not on any sedative drugs
- Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of> 4, dependent supervision on Functional Ambulatory category scale)
Who cannot join
- Severe osteoporosis (Ultrasound score < -2)
- Cognitive impairment (Mini Mental State Exam score<25)
- Aphasia (<71% on Mississippi Aphasia Screening Test)
- Severe depression ( > 15 on Geriatric Depression Scale)
- Severe obesity (BMI >35Kilogram/m2)
- Complains of shortness of breath, or uncontrolled pain (> 3/10 on VAS), or if pulse oxygen drops <92% on the 6 minute walk test (for endurance)
Show all 9Show fewer
- Uncontrolled hypertension (resting systolic blood pressure > 165 mmHg and/or diastolic blood pressure > 110mmHg)
- Resting heart rate > 85% of age-predicted maximal heart rate
- Resting oxygen saturation <95%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Perturbation Training for Enhancing Stability and Limb Support Control for Fall-risk Reduction Among Stroke Survivors
The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times higher risk of hip fracture than their healthy counterparts; with only less than 40% of those individuals regaining independent mobility. Falls, thus not only affect activities of daily living but also reduce mobility, increase risk of second stroke and mortality. Despite potential financial and functional implications of falls in this population, health-care personnel are limited in their ability to develop and validate interventions to reduce fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing paretic limb function. The project design consists of a randomized controlled trial to examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations to slip-perturbation training for not only mitigating fall risk but also improving walking function. It also explores translation of this paradigm to the sub-acute population. The paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on fall-risk through a bilateral training paradigm that involves training the non-paretic side first and then paretic to facilitate acquisition of fall-prevention skills on the paretic side, which may otherwise take longer to acquire training effects. The longer-term benefits of such perturbation training, targeting both limbs for reducing falls will be assessed not only in the laboratory but also in real life via wearable sensors, along with improved community walking function. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk not only in people living with hemiparetic stroke but also among survivors of other acquired unilateral cortical lesions.
Read the detailed description
Approximately 800,000 Americans suffer a stroke every year and 689,450 reported having short and long-term disabilities leading to dependence in activities of daily living. It has been reported that stroke survivors experienced detrimental falls each year and most occurring during walking. The likelihood of experiencing a fall upon discharge from rehabilitation being significantly higher than during the rehabilitative phase. Falls resulting from environmental perturbations such as slips contribute to a significant percentage of these falls. Hence, it is important to develop innovative and effective paradigms for fall-risk reduction in chronic as well as sub-acute stroke survivors. The purpose of this research is to understand the effect of bilateral slip-perturbation training protocol targeting training both paretic vs. non-paretic limbs on fall-risk reduction and prevention. Also, to find its effect on increasing community ambulation in community dwelling stroke survivors.
Participants in this study will be individuals with chronic (> 6 months) hemiparesis following stroke or individuals with sub-acute stroke (> 6weeks and < 6 months), ambulatory (with or without assistive device) and more than 21 years of age. Subjects will be screened for the inclusion criteria. If subjects pass the screening, they will go through the full clinical balance assessment and laboratory dynamic stability test. The chronic stroke survivors will be randomized into two groups: - Group A: Slip training group; Group B: Control group. While, the sub-acute stroke survivors will be randomized into two groups: - Group C: Slip training group; Group D: Control group.
For the slip training groups (A and C), all subjects' normal walking pattern and their recovery responses to slip will be recorded with a motion tracking system (including videotaping) while they walk across an instrumented area along a straight path in the lab. A slip will be induced after a subject steps on a low-friction platform.
For the chronic stroke subjects, baseline activity monitoring using wearable sensors will be performed for up to four weeks prior to the training session followed by activity monitoring for 12 months. While for the sub-acute stroke subjects, it would be done for 6 months.
For groups A and B, the follow-up stability test will be at 6 and 12 months post-training session, which will consist only of one slip induced on the training side and contralateral side. For groups C and D, follow-up session is 6 months post training session.
Incidence of falls and physical activity will be monitored between training and re-test sessions through falls, activity monitoring-questionnaire to describe details of the falls and through the wearable sensors for groups A, B, C and D.
- Conditions
- Stroke
- Being tested
- Overground slip perturbation training
- Keywords
- Fall risk, Stroke survivors, Perturbation training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overground slip perturbation trainingOther
Slips will be induced by a low-friction platform (65×30×0.6 cm, μ<0.05) embedded side-by-side in the walking path, set nearly flush with the floor surround. The moveable platform, mounted on top of a pair of force platforms (AMTI, Newton, MA) for measuring ground reaction forces is firmly locked in a stationary position. An unannounced release occurs at heel strike of the perturbed, without the knowledge of subject, after which the platform is free to slide up to 150 cm. The mechanical release is controlled by the loading on the force platforms and the computer.
| Study group | Role | What they receive |
|---|---|---|
| Slip training for chronic stroke | Experimental | Chronic stroke subjects in this training group will receive bilateral overground, slip perturbation training. Receives: Other: Overground slip perturbation training |
| Control for chronic stroke | No intervention | Chronic stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides. |
| Slip training for sub-acute stroke | Experimental | Sub-acute stroke survivors in this training group will receive bilateral overground, slip perturbation training. Receives: Other: Overground slip perturbation training |
| Control for sub-acute stroke | No intervention | Sub-acute stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory induced falls
Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by amount of force recorded on the load cell attached to the ceiling mounted safety harness system donned by the participant. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90~100% of subsequent falls (occurring ~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings.
Measured: Pre-training, immediate post-training, 6-month post training, 12-month post training
Change in real life falls
Real life falls are measured to determine if training effect can be translated into everyday real life setting.
Measured: Retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Secondary outcomes (6)
Change in Stability
Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity.
Measured: Pre-training, immediate post-training, 6-month post training, 12-month post training
Change in Limb support
The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.
Measured: Pre-training, immediate post-training, 6-month post training, 12-month post training
Change in gait speed
Gait speed will be computed from an average of three walking trials on the laboratory walkway.
Measured: Pre-training, 6-month post training, 12-month post training
Change in symmetry
Symmetry will be computed from an average of three walking trials on the laboratory walkway.
Measured: Pre-training, 6-month post training, 12-month post training
Change in gait speed during functional ambulation
The gait speed for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in ambulatory skills of the patient and decrease reliance on the assistive device.
Measured: One month before pretest till prospectively 12 months post training
Change in physical activity
The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device.
Measured: One month before pretest till prospectively 12 months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start26 Apr 2017
- Primary completion15 Apr 2024
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois Chicago
- Investigators
- Tanvi Bhatt, PhD PT, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205527
- Sponsor's protocol ID
- 2016-0933
- Other IDs
- 1R01HD088543-01A1
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2017
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatt T, Dusane S, Gangwani R, Wang S, Kannan L. Motor adaptation and immediate retention to overground gait-slip perturbation training in people with chronic stroke: an experimental trial with a comparison group. Front Sports Act Living. 2023 Sep 13;5:1195773. doi: 10.3389/fspor.2023.1195773. eCollection 2023.
PubMed 37780126Dusane S, Bhatt T. Can prior exposure to repeated non-paretic slips improve reactive responses on novel paretic slips among people with chronic stroke? Exp Brain Res. 2022 Apr;240(4):1069-1080. doi: 10.1007/s00221-021-06300-8. Epub 2022 Feb 1.
PubMed 35106605Gangwani R, Dusane S, Wang S, Kannan L, Wang E, Fung J, Bhatt T. Slip-Fall Predictors in Community-Dwelling, Ambulatory Stroke Survivors: A Cross-sectional Study. J Neurol Phys Ther. 2020 Oct;44(4):248-255. doi: 10.1097/NPT.0000000000000331.
PubMed 32815890
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perturbation Training for Enhancing Stability and Limb Support Control for Fall-risk Reduction Among Stroke Survivors
- ClinicalTrials.gov ID
- NCT03205527
- Acronym / sponsor ID
- 2016-0933
- Conditions
- Stroke
- Keywords
- Fall risk, Stroke survivors, Perturbation training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times higher risk of hip fracture than their healthy counterparts; with only less than 40% of those individuals regaining independent mobility. Falls, thus not only affect activities of daily living but also reduce mobility, increase risk of second stroke and mortality. Despite potential financial and functional implications of falls in this population, health-care personnel are limited in their ability to develop and validate interventions to reduce fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing paretic limb function. The project design consists of a randomized controlled trial to examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations to slip-perturbation training for not only mitigating fall risk but also improving walking function. It also explores translation of this paradigm to the sub-acute population. The paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on fall-risk through a bilateral training paradigm that involves training the non-paretic side first and then paretic to facilitate acquisition of fall-prevention skills on the paretic side, which may otherwise take longer to acquire training effects. The longer-term benefits of such perturbation training, targeting both limbs for reducing falls will be assessed not only in the laboratory but also in real life via wearable sensors, along with improved community walking function. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk not only in people living with hemiparetic stroke but also among survivors of other acquired unilateral cortical lesions.
Detailed description
Approximately 800,000 Americans suffer a stroke every year and 689,450 reported having short and long-term disabilities leading to dependence in activities of daily living. It has been reported that stroke survivors experienced detrimental falls each year and most occurring during walking. The likelihood of experiencing a fall upon discharge from rehabilitation being significantly higher than during the rehabilitative phase. Falls resulting from environmental perturbations such as slips contribute to a significant percentage of these falls. Hence, it is important to develop innovative and effective paradigms for fall-risk reduction in chronic as well as sub-acute stroke survivors. The purpose of this research is to understand the effect of bilateral slip-perturbation training protocol targeting training both paretic vs. non-paretic limbs on fall-risk reduction and prevention. Also, to find its effect on increasing community ambulation in community dwelling stroke survivors.
Participants in this study will be individuals with chronic (> 6 months) hemiparesis following stroke or individuals with sub-acute stroke (> 6weeks and < 6 months), ambulatory (with or without assistive device) and more than 21 years of age. Subjects will be screened for the inclusion criteria. If subjects pass the screening, they will go through the full clinical balance assessment and laboratory dynamic stability test. The chronic stroke survivors will be randomized into two groups: - Group A: Slip training group; Group B: Control group. While, the sub-acute stroke survivors will be randomized into two groups: - Group C: Slip training group; Group D: Control group.
For the slip training groups (A and C), all subjects' normal walking pattern and their recovery responses to slip will be recorded with a motion tracking system (including videotaping) while they walk across an instrumented area along a straight path in the lab. A slip will be induced after a subject steps on a low-friction platform.
For the chronic stroke subjects, baseline activity monitoring using wearable sensors will be performed for up to four weeks prior to the training session followed by activity monitoring for 12 months. While for the sub-acute stroke subjects, it would be done for 6 months.
For groups A and B, the follow-up stability test will be at 6 and 12 months post-training session, which will consist only of one slip induced on the training side and contralateral side. For groups C and D, follow-up session is 6 months post training session.
Incidence of falls and physical activity will be monitored between training and re-test sessions through falls, activity monitoring-questionnaire to describe details of the falls and through the wearable sensors for groups A, B, C and D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Slip training for chronic stroke | Experimental | Other: Overground slip perturbation trainingChronic stroke subjects in this training group will receive bilateral overground, slip perturbation training. |
| Control for chronic stroke | No intervention | –Chronic stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides. |
| Slip training for sub-acute stroke | Experimental | Other: Overground slip perturbation trainingSub-acute stroke survivors in this training group will receive bilateral overground, slip perturbation training. |
| Control for sub-acute stroke | No intervention | –Sub-acute stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will have to be ambulatory (with or without assistive device) with self-reported chronic (> 6 months) stroke-induced hemiparesis confirmed by participants' physician and medically cleared. Evidence of unilateral brain lesion confirmed by an imaging study (e.g. CT or MRI).
- Subjects with no other acute and significant neurological, cardiopulmonary, musculoskeletal or systemic diagnosis or have undergone a recent major surgery (<6 months) or hospitalization (<3 months) and not on any sedative drugs
- Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of> 4, dependent supervision on Functional Ambulatory category scale)
Key exclusion criteria (9 listed)
- Severe osteoporosis (Ultrasound score < -2)
- Cognitive impairment (Mini Mental State Exam score<25)
- Aphasia (<71% on Mississippi Aphasia Screening Test)
- Severe depression ( > 15 on Geriatric Depression Scale)
- Severe obesity (BMI >35Kilogram/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overground slip perturbation trainingSlips will be induced by a low-friction platform (65×30×0.6 cm, μ<0.05) embedded side-by-side in the walking path, set nearly flush with the floor surround. The moveable platform, mounted on top of a pair of force platforms (AMTI, Newton, MA) for measuring ground reaction forces is firmly locked in a stationary position. An unannounced release occurs at heel strike of the perturbed, without the knowledge of subject, after which the platform is free to slide up to 150 cm. The mechanical release is controlled by the loading on the force platforms and the computer. | Other | Slip training for chronic stroke, Slip training for sub-acute stroke |
Primary outcome
Change in laboratory induced falls
Time frame: Pre-training, immediate post-training, 6-month post training, 12-month post training
Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by amount of force recorded on the load cell attached to the ceiling mounted safety harness system donned by the participant. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90~100% of subsequent falls (occurring ~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings.
Change in real life falls
Time frame: Retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Real life falls are measured to determine if training effect can be translated into everyday real life setting.
6 secondary outcomes
Change in Stability
Time frame: Pre-training, immediate post-training, 6-month post training, 12-month post training
Change in Limb support
Time frame: Pre-training, immediate post-training, 6-month post training, 12-month post training
Change in gait speed
Time frame: Pre-training, 6-month post training, 12-month post training
Change in symmetry
Time frame: Pre-training, 6-month post training, 12-month post training
Change in gait speed during functional ambulation
Time frame: One month before pretest till prospectively 12 months post training
Change in physical activity
Time frame: One month before pretest till prospectively 12 months post training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 37780126Bhatt T, Dusane S, Gangwani R, Wang S, Kannan L. Motor adaptation and immediate retention to overground gait-slip perturbation training in people with chronic stroke: an experimental trial with a comparison group. Front Sports Act Living. 2023 Sep 13;5:1195773. doi: 10.3389/fspor.2023.1195773. eCollection 2023.
- Derived from this study: PubMed 35106605Dusane S, Bhatt T. Can prior exposure to repeated non-paretic slips improve reactive responses on novel paretic slips among people with chronic stroke? Exp Brain Res. 2022 Apr;240(4):1069-1080. doi: 10.1007/s00221-021-06300-8. Epub 2022 Feb 1.
- Derived from this study: PubMed 32815890Gangwani R, Dusane S, Wang S, Kannan L, Wang E, Fung J, Bhatt T. Slip-Fall Predictors in Community-Dwelling, Ambulatory Stroke Survivors: A Cross-sectional Study. J Neurol Phys Ther. 2020 Oct;44(4):248-255. doi: 10.1097/NPT.0000000000000331.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanvi Bhatt, PhD PT principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overground slip perturbation training in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in laboratory induced falls (time frame: Pre-training, immediate post-training, 6-month post training, 12-month post training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.